(86 days)
The Amelung AMAX CS-190 Coagulation Analyzer can be used for the detection of fibrin formation utilizing either mechanical principles (ball method) or photo-optical principles to perform clot based tests such as prothrombin time(PT), activated partial thromboplastin time (APTT), fibrinogen, factor assays, and other clotting tests. In addition, the AMAX CS-190 Coagulation Analyzer can be used for chromogenic assays such as antithrombin III (AT III).
The Amelung AMAX CS-190 Coagulation Analyzer is an automated random access multipurpose analyzer.
Here's an analysis of the provided text regarding the AMAX CS-190 Coagulation Analyzer, framed to address your specific questions about acceptance criteria and the supporting study:
The provided document does not explicitly state acceptance criteria in a clear, quantitative manner. Instead, it presents regression statistics (correlation coefficients, r, and linear regression equations) and coefficients of variation for precision. The implied acceptance criteria are that these statistical measures demonstrate "substantial equivalency" to predicate devices. Without explicit thresholds for 'r' values or 'CV' percentages that define "substantial equivalency," it's impossible to list precise acceptance criteria as requested.
The study presented is a comparison study of the AMAX CS-190 Coagulation Analyzer against existing predicate devices (TOA Medical Electronics CA-5000, BBL Fibrometer, and a manual spectrophotometric method). The goal is to demonstrate that the new device performs similarly to or as well as established methods.
1. Table of Acceptance Criteria and Reported Device Performance
As mentioned, explicit acceptance criteria are not defined in the provided text. The reported device performance is characterized by the correlation coefficient (r) and linear regression equations (y = mx + b) when compared to predicate devices, and coefficient of variation (CV) for precision.
| Test Type | Predicate Device / Method | Implied Acceptance Criteria (Not Explicitly Stated) | Reported Device Performance (r-value) | Reported Device Performance (Regression Equation) | Reported Device Performance (CV) |
|---|---|---|---|---|---|
| PT (optical) | TOA Medical CA-5000 | High correlation (r close to 1), slope close to 1, intercept close to 0 | 0.989 | y = 1.113x - 0.9 |
§ 864.5425 Multipurpose system for in vitro coagulation studies.
(a)
Identification. A multipurpose system for in vitro coagulation studies is a device consisting of one automated or semiautomated instrument and its associated reagents and controls. The system is used to perform a series of coagulation studies and coagulation factor assays.(b)
Classification. Class II (special controls). A control intended for use with a multipurpose system for in vitro coagulation studies is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.